Ventilation/Perfusion PET/CT with Galligas and 68Ga-MAA for Regional Lung Function Assessment After Pulmonary Embolism

Launched by UNIVERSITY HOSPITAL, BREST · Oct 21, 2021

Keywords

ClinConnect Summary

The "RAMBO" trial is studying how effective pulmonary rehabilitation (PR) is for patients who have had a pulmonary embolism (PE) and are experiencing ongoing breathing difficulties and reduced quality of life, even after receiving anticoagulant therapy for at least three months. The trial aims to see if participating in a structured rehabilitation program can help improve these patients' wellbeing. As part of this study, the EOLE pilot study will use advanced imaging called Ventilation/Perfusion PET/CT scans to evaluate lung function before and after the rehabilitation.

To be eligible for this trial, participants must be at least 18 years old, have been treated for a PE with anticoagulants for 3 to 8 months, and show signs of continued breathing issues or a poor quality of life despite treatment. Patients will undergo a thorough assessment and, if selected, they can expect to participate in rehabilitation sessions designed to improve their lung function and overall health. This trial is currently recruiting participants, and it’s important for interested individuals to discuss their eligibility with their healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient included in the RAMBO study, whose inclusion criteria are: Age ≥ 18 years; Patient treated with at least 3 months and up to 8 months of anticoagulation for an acute symptomatic PE diagnosed according the ESC and ACCP guidelines; Patients who have a PembQol score ≥ 10% and whose total scores for the subgroups Q1 (dyspnea) and Q4 (impact of daily life) are ≥ 10%.
• • Patients planned to be randomized
• • Abnormal conventional V/Q scan at V1
• • Give consent to participate to the EOLE study
• Exclusion Criteria:
• * Non inclusion criteria of the RAMBO trial:
• • Previsible inability to perform the effort test and/or PR
• • Presence of CTEPH according to international guidelines
• • Patients treated for acute PE with anticoagulants for more than 8 months
• • Active cancer or in remission for less than two years
• • Dyspnea post - COVID due to parenchymal injuries
• • Post-COVID hyperventilation syndrome without pulmonary vascular perfusion sequelae
• • Physical or psychological inability to undertake PR
• • Isolated or more distal segmental PE
• • Neuro-muscular disease with PR contraindication.
• • Cardiac insufficiency (unstable coronary artery disease)
• • Severe respiratory failure (long-term oxygen therapy, pulmonary hypertension)
• • Chronic dyspnea MMRC ≥ 2 before PE
• • Cardiac or respiratory rehabilitation in the previous year
• • Indication to urgent PR within 6 months at the time of inclusion
• • Life expectancy of less than 12 months
• • Inability to give consent
• • Patient under guardianship or curatorship
• • Patient deprived of liberty by an administrative or judicial decision
• • Patient has not social security affiliation or who don't beneficiary of such social security
• After initial PR work up, patients with following criteria cannot be included:
• • Incapacity to perform the effort test
• • Effort test stopped because of hemodynamic intolerance
• • Cardiac failure discovered after PR work up